Quality Business Owner (PQR)

Role Summary

Quality Business Owner (PQR) located in Framingham, MA. Owns process, system and data within the Quality Systems Team, establishing and prioritizing process evolutions for the site, supporting audits and inspections, and identifying remediation actions from audit findings under the global process owner.

Responsibilities

• Conduct routine data quality checks and validations to identify and address any process, system or data issue.
• Develop and deliver training programs, principles and best practices.
• Identify and assess risks and implement mitigation strategies.
• Lead continuous improvement initiatives on-site in line with global processes and practices.
• Oversee computerized systems to ensure they meet all requirements.
• Establish and monitor key performance indicators in line with global guidance.
• Represent the site in the CoP and, when requested, participate in the CoE while ensuring local communication.
• Represent Sanofi global quality when interacting with health authorities for global processes.
• Oversee overall QMS health at the Mass BioCampus facilities to ensure quality and compliance.
• Compile data for and ensure compliance with procedures governing Quarterly Management Reviews, Product Quality Reviews, Site Quality Council, Site Risk Profile, and investigation system maintenance for site needs.

Qualifications

• Required: Bachelor‚Äôs degree in science or a relevant field.
• Required: 5+ years of experience in quality or manufacturing within the pharmaceutical/biotech industry.
• Required: Ability to analyze complex data sets and identify patterns, discrepancies, and areas for improvement (Power BI and Excel).
• Required: Experience reviewing and reporting KPIs.
• Required: Strong focus on continuous improvement with the ability to implement plans successfully.
• Required: Strong verbal and written communication skills with the ability to work collaboratively with others.
• Preferred: Experience with change controls and complaints.
• Preferred: Experience working with global partners.
• Preferred: Experience with deviations and CAPA management.

Skills

• Data analysis
• Quality management systems
• Process optimization
• Training and development
• Regulatory liaison
• KPI development and monitoring

Education

• Bachelor‚Äôs degree in science or a relevant field

Additional Requirements

• None specified